Balloon Expandable Biliary Stent Instructions for Use - eV3

STENT AND PTA BALLOON CATHETER
ASSEMBLY PREPARATION
1. Select a stent and non-compliant PTA
balloon dilation catheter for the duct into
which the stent will be implanted. The
nominal diameter of the balloon should
approximate the diameter of the obstructed
duct and intended implant site.
NOTE: Use a balloon that requires a 7 Fr or a
larger sheath. A smaller balloon may not have
a large enough diameter to allow optimal
crimping of the stent to the balloon.
2. Remove the stent from the package and rinse
in sterile saline.
3. Remove the balloon catheter from the sterile
package in preparation for stent mounting.
4. Preinflate the balloon to ensure the balloon
opens uniformly.
5. Refold the balloon per manufacturer’s
instructions.
6. Visually inspect the balloon to assure that it is
properly folded to its lowest profile before
stent application.
7. If balloon has a lubricious coating, use a
saline saturated sterile gauze to gently wipe
the folded balloon to reduce the lubricious
coating.
8. Carefully insert the distal tip of the
unexpanded balloon, while maintaining
balloon fold into the angled end of the stent
mounting tube (Figure 1.)
9. While holding the cap of the mounting tube,
gently pinch the mounting tube behind the
stent and slide the stent onto the balloon.
(Figure 2). Do not compress the stent on the
mounting tube. This may potentially crimp
the stent to the mounting tube (Figure 2a).
10. Continue to slide the stent over the balloon
while using the balloon radiopaque markers
for centering the balloon (Figure 3).
11. Gently using the thumbs and index fingers of
both hands, crimp the stent onto the balloon
from all directions to ensure full adherence of
the stent to the balloon.
12. Flush the balloon catheter lumen with saline,
then load the stent/delivery assembly onto
the guidewire.
13. Apply a pressure of one atmosphere to the
balloon to slightly preinflate both balloon
cones.
14. Verify both balloon cones are slightly inflated.
15. Maintain this low pressure during insertion of
the stent/delivery assembly.
STENT/DELIVERY ASSEMBLY
INSERTION
1. The stent/delivery assembly is advanced
through the appropriate sized sheath, over
the guidewire into correct position. If a
hemostatic valve is present on the introducer
sheath, a metal introducer tube can be used
to facilitate advancement of the stent.
2. Position the stent across the target stricture.
The distal portion of the stent should be
positioned so that it completely covers the
distal extent of the stricture.
NOTE: Care should be taken to fully cover
the area proximal and distal to an inoperable
malignant tumor with the stent to protect
against impingement from further tumor
growth.
3. Pull back on the sheath to fully expose the
stent. Expand the stent by inflating the
balloon catheter to the nominal inflation
pressure. Appropriate expansion of the
balloon/stent should be determined using
fluoroscopy. Do not exceed the balloon
catheter manufacturer’s recommended
maximum balloon inflation pressure.
4. The diameter of the stent can be sized to the
lumen of the bile duct.
5. Deflate the balloon.
6. Rotate the deflated balloon delivery catheter
to ensure the stent is free and properly
deployed.
7. Remove the delivery catheter.
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